Saline vs. Silicone Mountain View
Types of Breast Implants – Ideal implant Saline, regular Saline and Silicone-Gel Filled Implants, “Gummy-Bear” or Form-Stable gel implants
Gel or “silicone gel” filled implants have become the frequent choice of women considering breast augmentation since the FDA released them for all women over the age of 22. This is because they are soft, feel very natural, and much less likely to be visible through the skin. Unlike regular saline implants, they do not have that “ripply” feeling at the bottom or side of the breast in women who have little soft tissue of their own to cover them. They are an ideal implant in terms of feel, for thin women, for this reason.
However, there is now a saline-filled implant that feels like a gel implant. If you were to feel it under a thin cloth, side by side with a gel implant, particularly a high-profile gel implant, you would have difficulty telling the difference. This implant is called the Ideal implant, and more information can be found at Idealimplant.com.
This implant is now available in my practice. It’s use is only available to the clinical investigators who took part in the FDA approval process, and plastic surgeons who have invested in the company. My disclaimer is that I am an investor in the company because I wanted to make this implant available to my patients.
The Ideal saline implant does not feel wrinkly or bouncy or ripply like the usual saline implant. It was developed by a plastic surgeon, Dr. Robert Hamas, MD, of Dallas and has received FDA approval as of October, 2014. It is available as of September, 2015 for plastic surgeons to offer to their patients, but only a small number of plastic surgeons in the Bay Area have the ability to offer it to their patients. Our practice is one of them.
The Ideal implant has several internal shells, and two compartments to hold saline, one in front, and one in back. The one in back is filled to a fixed volume for that implant size, and the one in front can be filled within a range. Between the two compartments are multiple internal shells with perforations in them that allow saline to flow. This arrangement makes the implant soft to the touch without wrinkling. Compared to a regular saline implant that bounces when dropped on a surface, the Ideal saline implant behaves identically to a gel implant; both do not bounce.
Why consider a new saline implant that feels like gel? Why not just use gel? While no implant is perfect, gel implants require an MRI in most cases to know if they are ruptured. That is why it is called “silent rupture” when referring to the phenomenon in gel implants. Usually the patient does not know there is a leak. The FDA initially recommended that women check their gel implants for silent rupture at three years and every three years thereafter. Memorial-Sloan Kettering Hospital published a study suggesting that the initial rupture rate was low enough that it made sense to wait up to six or seven years, Nevertheless the FDA recommendation has not been altered.
The FDA has published 10 year follow-up results of post-implant rupture rates as determined by MRI, in the group of women who agreed to be part of this long-term study. All manufacturers, Mentor, Allergan and Sientra were required to participate as a condition of having their implants on the market for breast augmentation.
FDA Update on the Safety of Silicone Gel-Filled Breast Implants
The ten-year cumulative incidence of silicone gel implant rupture in this report was 10.1% for Allergan Natrelle; 13.6% for Mentor at eight years; 17.7% for Allergan 410 anatomic form-stable gel (gummy bear).
Health Canada, January 2014, reported that the ten-year rupture rate for Mentor gel implants was 24.2%.
So despite the excellent track record of gel implants, and the satisfaction of women who have them and enjoy their natural feel, there is the question of silent rupture and the fact that women will in most cases not know they have a gel implant rupture unless they get an MRI.
For those women who would like a saline implant because they know that when it ruptures, it will get smaller and they will know it has ruptured, the uncertainty would be removed. Saline is harmless and is absorbed by the body. Because the Ideal implant has two compartments containing saline, a leak would not result in full deflation, making it less of an urgent matter to get the implant replaced.
Women who might have wanted to have the security of knowing when their implant was leaking, but were not willing to accept the trade-offs of more firmness, more wrinkling or rippling or shell visibility through thin skin, might be more willing to consider a saline implant if there was one that felt like a gel implant. This is the reason that the Ideal implant was developed.
It’s place among implant choices is for those women who want a natural-feeling breast implant, the feel of gel, but not the uncertainty of knowing if their implant is ruptured without getting an MRI, as is the case for gel.
Because the long-term rupture rates for gel implants are turning out to be so much higher than they were thought to be in the first five years, the Ideal implant which costs about the same as a gel implant, is now available as an alternative.
The form-stable, or “gummy bear” implants made by Sientra and marketed worldwide received FDA approval for sale in the US in 2012. Mentor and Allergan have also received approval since then. These implants hold their shape and are made in round and anatomic tear drop shapes. Their profile is more like the natural breast with more projection in the lower part. The come in round, oval and tear-drop, with varying sizes and projections. Women can have a customized look depending on their goals and anatomy. When cut the gel stays in place and does not distribute around the pocket. View the Sientra video to observe this.
Because form-stable implants must be oriented vertically, their surfaces are textured to grab and integrate with adjacent tissue. They are currently the most expensive choice in gel implants.
There is some maintenance or upkeep associated with gel implants. The FDA recommends that women get an MRI (magnetic resonance imaging) test at 3 years after implantation to check for “silent rupture”. It is called “silent” because when a gel implant leaks you cannot tell. The silicone gel stays in the pocket, so the breast stays the same size. A woman may be unable to tell that there is a leak in the implant unless there is some change in shape or feel. With a saline implant, when the implant begins to deflate as the saline is absorbed, it is clear that there is a deflation problem.
If a leak in a gel implant is not detected, over a period of time, a gradually increasing number of women may get some gel into tissues adjacent to the pocket, and when this happens, the body will wall off the gel. This may cause a lump or some area of discomfort and will have to be investigated, like any lump in the breast, to make sure it is not cancer. With an MRI or ultrasound, this should not be a problem, but it is better to detect the leak before it gets outside the pocket, hence the recommendation for periodic MRI’s. Longer-term studies are in progress to see if the recommended interval for MRI’s could be longer than every 2 years after the initial one. Recent studies have compared highly-specific ultrasound very favorably with MRI, so that may be an alternative in the future. Other studies that are becoming available include 3-D mammograms and highly specific ultrasound.
There has been a steady evolution and improvement in implant manufacturing and design such that the gel-filled and saline breast implants available today are greatly improved over previous generations. They are more durable, available in more shapes for specific augmentation needs, and have either smooth or textured surfaces.
The Food and Drug Administration (FDA) allows silicone gel-filled breast implants as well as saline-filled breast implants for cosmetic augmentation. In addition to the information being provided here the FDA has Information for Women Considering Saline-filled or Silicone Gel Breast Implants at their website.
It is in the nature of medical technology to gradually evolve. New implant filler materials and implant designs are being actively researched. We can expect these to gradually become available and widen our choices. This does not mean that today’s breast implants will be obsolete. With currently available gel and saline implant technology, it is possible to achieve better results, with a much more natural-appearing breast than ever before.
Nevertheless, it is in the nature of breast implants that a woman might someday either want or need to have another procedure. The reasons for doing so include the following:
- Simply a desire for a larger size. Since the size of the implant that can be initially placed in a woman with a tight skin envelope is limited, a larger size may be possible after the skin envelope has had time to expand.
- Capsular contracture, or hardening of the breast that can occur due to thickening of the fibrous capsule around the implant. Should this occur, removal of the capsule is recommended whenever the capsule is firm enough to distort breast shape or position.
- New implant development that offers a substantial gain in desired characteristics of durability, feel, or appearance.
- Deflation of a saline-filled implant.
Shell Surfaces and Silicone Gel Implants
There are two types of shell surface available in breast implants, smooth and textured. Textured shell breast implants do not have any advantages, in my experience over smooth implants. The textured surface is necessary, however, for asymmetrical implants, e.g. form-stable implants, so they will not rotate, but stick in their proper orientation. It has been claimed that there may be a smaller incidence of capsular contracture with textured implants. I have not seen any such difference. The risk of capsular contracture using the saline implants has been exceedingly low in my practice. There were no known contractures in my patients during the four year period from February, 2003, to early 2007. And the overall incidence as of June, 20124was under 1.5 percent.
Silicone Gel breast implants available since December, 2006, for first-time breast augmentation patients, seem to have even a lower risk of capsular contracture in my practice. The implants used in the 1980′s were not the same as the very low gel bleed implants available today. They allowed more gel to migrate through the shell. Theoretically, this was a factor in triggering capsular contracture. Since the incidence of capsular contracture remains so low in my prractice, textured implants are only used for special situations. For example, women who come to our breast implant revision practice who have pre-existing contractures are candidates for textured implants.